Recruiting NCT04745221

Efficacy and Safety of Auto-FMT in Preventing aGVHD

No phase Interventional Graft Versus Host Disease, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: autologous fecal bacteria.
Who it may be relevant to: Registry conditions: Graft Versus Host Disease, Acute. Basic parameters: 18 years — 60 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of Autologous Fecal Bacteria Transplantation in Preventing Acute Graft Versus Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation: a Multicenter, Open, Randomized Controlled Clinical Study

Overview

To evaluation the efficacy and safety of autologous fecal bacteria transplantation in preventing acute graft versus host disease after haploidentical hematopoietic stem cell transplantation. Bone marrow transplant patients were recruited.

Interventions

Other autologous fecal bacteria
autologous fecal bacteria transplantation

Primary outcome measures

Acute Graft-Versus-Host Disease [Time frame: 90 days after haploidentical hematopoietic stem cell transplantation]

Secondary outcome measures (2)

overall survival [Time frame: 90 days after haploidentical hematopoietic stem cell transplantation]
Event free survival [Time frame: 90 days after haploidentical hematopoietic stem cell transplantation]

Eligibility criteria

Inclusion criteria

Haplo-HSCT patients; Bacteroidetes >0.1%; inverse Simpson diversity ≥2

Exclusion criteria

Gastrointestinal diseases；Age>60; or Age<10；Probiotics or prebiotics were taken before enrollment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Single group
Masking: Open label
Primary purpose: Prevention

Study locations

China · 1 center

Ye Zhao — Suzhou

Identifiers

NCT: NCT04745221 · FMT2021001

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗